130 DEGREE TARGETING DEVICE 3371-0-130

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1993-03-09 for 130 DEGREE TARGETING DEVICE 3371-0-130 manufactured by Howmedica, Inc..

Event Text Entries

[17420705] 130 degree gamma nail implanted. Surgeon was able to (with difficulty) get the proximal screw inserted - as he targeted the distal hole - targeting device created a posterior positioned hole - was unable to do freehand screw placement - hole abondonedevice labeled for single use. Patient medical status prior to event: unknown. There was not multiple patient involvement. Invalid data - on device service/maintenance. No data - regarding date last serviced. Service provided by: invalid data. Invalid data - service records availability. No imminent hazard to public health claimed. Invalid data - whether device used as labeled/intended. Invalid data - regarding evaluation by user after event. Method of evaluation: none or unknown. Results of evaluation: none or unknown. Conclusion: none or unknown. Certainty of device as cause of or contributor to event: yes. Corrective actions: none or unknown. Invalid data - on device destroyed/disposed of status.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number33462-1993-09002
MDR Report Key2622
Date Received1993-03-09
Date of Report1993-01-09
Date of Event1993-01-09
Date Facility Aware1993-01-09
Report Date1993-01-09
Date Reported to FDA1993-01-09
Date Reported to Mfgr1993-01-09
Date Added to Maude1993-03-22
Event Key0
Report Source CodeDistributor report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Reporter OccupationUNKNOWN
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand Name130 DEGREE TARGETING DEVICE
Product CodeHLP
Date Received1993-03-09
Catalog Number3371-0-130
OperatorOTHER HEALTH CARE PROFESSIONAL
Device Availability*
Implant FlagY
Device Sequence No1
Device Event Key2448
ManufacturerHOWMEDICA, INC.


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 1993-03-09

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.